FIELD OF THE INVENTIONThe present invention concerns an adhesive bandage, in particular, for application on an acutely affected area of the epidermis which is very sensitive to contamination by bacterial germs and must remain sterile and, notably, an area containing a site for the implanting of an arteriovenous fistula forming a vascular access to a patient on hemodialysis, the said adhesive bandage comprising a support having an adhesive side, a sterile pad positioned on the said adhesive side of the support and a protective film covering the adhesive side and the sterile pad, the said protective film being made up of a first and second detachable tab, the said first detachable tab being folded back on itself along a folding line, outside the sterile pad area, and comprising a first flap applied on the adhesive side of the support and which extends at least from a first extremity of the said support towards its interior until the said folding line so as to cover entirely the sterile pad, and a second flap consisting of a beginning which tears off from the said first flap and which extends over the said first flap from the said folding line in the direction of the said first extremity of the support, the said second detachable tab comprising a third flap applied on the adhesive side of the support and which extends, outside of the sterile pad area, at the least from a second extremity of the said support, opposite the said first extremity, towards the interior of the said support until the said folding line of the first detachable tab.
BACKGROUND OF THE INVENTIONAn adhesive bandage of the type described above is presented by the American patent U.S. Pat. No. 5,397,297. Its second detachable tab, shorter than the first, also folds back on itself in the shape of a V. It consists of a fourth flap, which tears off and which extends over the third flap from the folding line beyond the second extremity of the support.
The sole aim of this patent is to present a particular packaging for a band age in an individual wrapping which facilitates the application of the bandage, without giving any guarantee for the sterility of this application. The two tearing flaps of the two tabs are sealed inside opposite extremities of the wrapping, forming two traction areas. This wrapping comprises, as well, on a longitudinal edge, a notch that is aligned with the folding line of the two tabs, as well as an area of prehension, facing the second tab and the bandage support.
To apply the bandage, the user must hold the wrapping in its prehension area then pull on the first traction area, connected to the tear-off flap of the first tab. The wrapping tears in two sections along the folding line of the tabs. The first tab, which entirely covers the pad, is pulled back first from the adhesive side of the support. The second tab stays in place on the support. From then on, there is a very high risk that the surrounding air or the user's fingers will contaminate, with bacterial germs, the pad and the large section of the support's adhesive side, which are uncovered. When this contaminated section is applied to the affected area of the skin, the germs it contains can cause serious infections.
Another adhesive bandage of a similar type is described in the English patent application published under the number GB-A-2 224 445. This bandage comprises a support provided with an adhesive surface which is protected by two detachable tabs. The first tab is folded back on itself in a V. It defines a first flap, applied on a small section of the adhesive surface towards the interior of the support from a first extremity, and a second flap which tears off from the first tab extending towards the exterior of the support beyond its first extremity. The second tab is more or less flat. It defines a third flap, applied on a large section of the adhesive surface towards the interior of the support from its second extremity, and a fourth flap, tearing from the second tab, which covers the first tab and extends beyond the first extremity of the support.
This adhesive bandage does not comprise a sterile pad on the adhesive surface for application on the affected area of the epidermis. The sole object of this patent application is to propose an adhesive bandage which is easy to apply, without offering any guarantee for the sterility of this application. Moreover, the second tab, whose third flap covers the large section of the support's adhesive surface, must be pulled back first. Therefore, there is a very high risk of serious contamination, by the surrounding air and by the user's fingers, of a large section of the adhesive surface before its application to the affected area of the skin, which would, itself, become seriously infected.
It is known other adhesive bandages similar to those previously described, notably in the international patent application published under the number WO 97 28771 and the European patent application published under the number EP-A-0 308 122. These bandages have various disadvantages and, in particular, do not guarantee systematic sterile application and present high risks of contamination to the affected area of the epidermis.
Consequently, the previous adhesive bandages are unsuitable for application on an acutely affected area of the epidermis which is very sensitive to contamination by bacterial germs and must remain sterile and for which a risk, even minimal, of contamination is not admissible.
SUMMARY OF THE INVENTIONThe present invention proposes to overcome this major disadvantage by providing an adhesive bandage which can be packaged under sterile conditions before use and which is provided with a protective film allowing the bandage to be manipulated without special precaution and for the adhesive side and the sterile pad of the support to be easily applied, even with one hand, to the patient's skin under systematically sterile conditions.
This aim is achieved by an adhesive bandage such as described in the preamble and characterised in that the said second detachable tab is designed to be lifted from the adhesive side of the support before the first detachable tab, in that the said second flap extends over the said first flap at least beyond the sterile pad area in the direction of the said first extremity of the support, and in that the said second detachable tab comprises a fourth flap with a beginning which tears off from the said third flap and which extends over the said first detachable tab from the said folding line at least beyond the sterile pad area in the direction of the said first extremity of the support.
The said fourth flap preferably has a length greater than that of the said first flap and extends beyond the said first extremity of the support.
The said second flap preferably has a length greater than that of the said first flap and extends beyond the said first extremity of the support.
In one advantageous embodiment, the said second flap has a length greater than that of the said fourth flap and extends beyond the said fourth flap.
BRIEF DESCRIPTION OF DRAWINGSThis invention and its advantages will be more apparent from the description of a preferred embodiment of the invention and with reference to the annexed drawings in which:
FIG. 1 is a lateral sectional view of the adhesive bandage of the invention,
FIG. 2 is a view of the underside of the adhesive bandage in FIG. 1, and
FIGS. 3ato3grepresent the sequences for application of the adhesive bandage in FIGS.1 and2.
DESCRIPTION OF THE PREFERRED EMBODIMENTTheadhesive bandage10 comprises asupport11, of, for example, a substantially rectangular shape, provided with anadhesive side12 and asterile pad13 positioned on thisadhesive side12, for example in its central zone. Thebandage10 also comprises a protective film, subject of the invention, which is made up of twodetachable tabs14 and15.
Thefirst tab14 is folded back on itself along afolding line16 substantially perpendicular to the longitudinal axis of thesupport11 and outside the area of thesterile pad13. It consists of afirst flap17 which is applied on theadhesive side12 of thesupport11. Thisflap17 extends from a first extremity of thesupport11 towards its interior until thefolding line16, in such a way as to cover completely thesterile pad13. Thefirst tab14 also has asecond flap18 consisting of a beginning which tears off from thefirst flap17. Thissecond flap18 extends over thefirst flap17, beyond the area of thesterile pad13, from thefolding line16 in the direction of the first extremity of thesupport11. It has a length greater than that of thefirst flap17 and extends beyond this first extremity of thesupport11.
The seconddetachable tab15 is substantially flat and has no folding zone. It comprises athird flap19 which is applied on theadhesive side12 of thesupport11. Thisflap19 extends, outside of the area of thesterile pad13, from a second extremity of thesupport11, opposite its first extremity, towards the interior of thesupport11 until thefolding line16 of thefirst tab14. Thesecond tab15 comprises afourth flap20 consisting of a beginning which tears off from thethird flap19. Thisfourth flap20 extends over thefirst tab14, beyond the area of thesterile pad13, from thefolding line16, in the direction of the first extremity of thesupport11. It has a length greater than that of thefirst flap17 and extends beyond the first extremity of thesupport11. Thisfourth flap20 of thesecond tab15 is favourably shorter than thesecond flap18 of thefirst tab14 so that thissecond flap18 extends beyond thefourth flap20.
Before use, theadhesive bandage10 is packaged under sterile conditions in a closed, individual package or wrapping24 (only diagrammatically shown in FIG.1). This wrapping24 forms an absolute barrier against germs and can also be impervious to liquids. To facilitate its opening, it can have a pre-fold or a notch, so that the user can easily open it, for example by tearing, without risk of damage to the bandage contained in it. Thebandage10 is placed in this wrapping24 in the initial configuration described previously and illustrated by FIGS. 1 and 2, in whichflaps17,18 of thefirst tab14 and thefourth flap20 of thesecond tab15 are superposed, over the area of thesterile pad13.
We shall now describe the application of theadhesive bandage10 with reference to FIGS. 3ato3gwhich represent the different sequences of the application.
Firstly, the user tears the wrapping and takes in one hand, theadhesive bandage10 contained in the wrapping. Thesecond tab15 covers theadhesive side12 over the small section of thesupport11, defined between the second extremity of thesupport11 and thefolding line16, as does thefirst tab14 over the large section of thesupport11, defined between thefolding line16 and the first extremity of thesupport11, which contains thesterile pad13. Thesecond tab15 therefore effectively protects these two sections from any contamination by the surrounding air and by the user's fingers. Only the inferior side or exterior side of thesecond tab15 can be contaminated but this does not constitute any risk of subsequent contamination for the patient during application of theadhesive bandage10, as will be explained below. The user can therefore manipulate the bandage without particular precaution.
We now refer to FIG. 3a. Firstly, the user grips in one hand the second extremity of thesupport11 with thethird flap19 of thesecond tab15, then, with the other hand, takes thesecond flap18 which tears off from thefirst tab14, what is relatively easy as thisflap18 extends beyond thefirst flap17 and beyond thefourth flap20. Next, referring to FIG. 3b, he takes with his first hand thefourth flap20 tearing from thesecond tab15, which extends beyond the first extremity of thesupport11. At this moment, thesecond flap18, from the side corresponding to thefourth flap20, has never been in contact with the user's fingers and is therefore still sterile on the large section of thesupport11, to the right of thefolding line16 and containing thesterile pad13. The user then pulls thefourth flap20 towards the second extremity of thesupport11, in the direction indicated by the arrow A, to unstick thethird flap19 from the small section of theadhesive side12 of thesupport11, to the left of thefolding line16, see FIG. 3c.
This section of theadhesive side12, which is still sterile, may be applied on theskin21 of the patient at the appropriate place, that is, next to the affectedarea22 of the epidermis which needs to be covered at the end of the application by thesterile pad13, as thethird flap19 is being detached from the adhesive12 and it is uncovered. This limits its exposure to the surrounding air.
It should be noted that thethird flap19 can be detached entirely from the small section of theadhesive side12, as represented in FIG. 3c, before this is stuck to theskin21 of the patient, which allows the application of theadhesive bandage10 to be terminated with one hand only. In this case, the small uncovered section of theadhesive side12 is only lightly and for a very short time in contact with the surrounding air and remains almost sterile. However, a minimum contamination of theadhesive side12 outside of thesterile pad area13 does not pose any risk of contamination to the affectedarea22 adjacent to the epidermis, which will be covered at the end of the application by thesterile pad13.
Referring now to FIG. 3d, the small section of theadhesive side12, to the left of thefolding line16, is from now on stuck to theskin21 of the patient. The inferior side of thesecond flap18, which up till now was protected by thefourth flap20 of thesecond tab15, is now facing theskin21 of the patient and the affectedarea22 of the epidermis. However, this side of thesecond flap18 has never been in contact with the user's fingers, in particular in thesterile pad13 area, and can therefore touch the affectedarea22 of the epidermis without any risk of contamination. It should also be emphasized that the large section of theadhesive side12 of thesupport11, to the right of thefolding line16, and thesterile pad13 are still totally covered by thefirst flap17 of the firstdetachable tab14 and are still perfectly sterile.
Finally, referring to FIGS. 3eto3g, the user pulls thesecond flap18, tearing from the firstdetachable tab14 towards the exterior of thesupport11, in the direction indicated by the arrow B, to unstick thefirst flap17 of the large section of theadhesive side12 of thesupport11, to the right of thefolding line16. Theadhesive side12 of thesupport11 is uncovered and sterile and, as it is being uncovered, sticks to theskin21 of the patient. Thesterile pad13 has therefore been applied under perfectly sterile conditions on the affectedarea22 of the epidermis.
The protective film of theadhesive bandage10 of the invention has a number of advantages. The seconddetachable tab15 of the protective film effectively protects thebandage10 when it is removed from its wrapping and allows it to be manipulated without special precaution and without any risk of subsequent contamination to the patient. Theflaps18,20 tearing from thedetachable tabs14,15 allow easy application of thebandage10 to the skin, even with only one hand and under systematically sterile conditions. This is because the sides of theflaps17 to20, which could be in contact with the affectedarea22 of the epidermis during application of thesupport11, have never been in contact with the user's fingers. They are therefore still sterile and there is no risk of contamination. Furthermore, theadhesive side12 and thesterile pad13 of thesupport11 are applied rapidly to theskin21 of the patient, as soon as they are uncovered, which also removes the risk of contamination by the surrounding air.
Theadhesive bandage10 of the present invention is particularly well adapted to applications requiring optimum sterile conditions and for which the slightest risk of contamination of the affected area of the epidermis can have serious, even fatal, consequences, and must be prevented. Examples of critical applications are those performed in an operating theatre, notably for the covering of laparotomy or thoracotomy wounds, burns or similar.
A particularly critical application of an adhesive bandage would be in the area of dialysis. A patient suffering chronic renal problems has to follow regularly, sometimes daily, a treatment of blood dialysis in a hospital environment or at home. At each session, an artery and a vein of the patient's circulatory system must be connected to a dialysis machine to purify the patient's blood. So as to facilitate this treatment and relieve the patient, the patient has an implanted arteriovenous fistula permanently during surgical procedure. This is implanted under the epidermis of the upper-arm and is connected at each session to the dialysis machine. This gives permanent vascular access to the patient and must always be covered with a sterile adhesive bandage for two reasons. The bandage serves, partly, to maintain the fistula's vascular access at the patient's upper-arm as, should this be lost, surgery would then be needed to recreate it. Principally, however, it serves to protect it from contamination by bacterial germs so as to avoid a latent septicaemia in the patient, who is already ill and fragile. To guarantee protection and lasting sterility, the adhesive bandage applied to the arm must be replaced regularly, at least after each session, and often by the patient himself. This would necessarily be with one hand. Consequently, the adhesive bandage used must systematically allow for perfectly sterile application, even with one hand, without the risk of any subsequent contamination. Theadhesive bandage10 of the invention responds to all these stringent criteria of application.
Of course, theadhesive bandage10 of the invention suits other, less serious, applications as far as sterility is concerned. The adhesive bandage can be the occlusive type, thesupport11 and thesterile pad13 then being gaspermeable but impervious to liquids and to bacteria. Thesupport11 can be transparent, made, for example, from polyurethane, so that the surface of the coveredskin21 is visible. Theadhesive side12 can equally be hypoallergenic. Theadhesive bandage10 may be hydroactive, thesterile pad13 then containing water with additional agents allowing decomposition, for example to promote the healing of a wound. Theadhesive bandage10 can have any dimensions, be small or large, and be any shape, rectangular, oval or circular, for example.
The adhesive bandage can be produced simply and economically on conventional machines. Onedetachable tab14 is folded back on itself, while the otherdetachable tab15 does not have a folding section. As thesecond tab15 covers the support over its entire length, the relative tolerance of its position from thefolding line16 of thefirst tab14 on theadhesive side12 can be large. It needs only be situated outside the area of thesterile pad13. The folding of thedetachable tab14 is always done outside the area of thesterile pad13, the latter conserving all its effectiveness. Moreover, theadhesive bandage10 can be packaged under sterile conditions in any sort of individualized wrapping, as the seconddetachable tab15 protects thebandage10 effectively when it is removed from its wrapping.
The present invention is not limited to the types of implementation already described and illustrated but extends to any modification and variant evident for those in the profession. For example, thesupport11 may be covered on its superior non-adhesive side, with a layer of detachable reinforcement which is removed after application of the support on the skin. This means, firstly, that the support does not become creased during application if it is too soft, but, also, that contact with the fingers on the superior side of the support is avoided, and so improves the sterility of the application.
To guarantee the sterility of the application of thepad13 on the affected area of the epidermis, the only essential is that thefourth flap20 of the seconddetachable tab15 extends over thesecond flap18 of the firstdetachable tab14 and that the two tearingflaps18,20 extend from thefolding line16, at least beyond the area of thesterile pad13 in the direction of the first extremity of thesupport11. The fact that these twoflaps18,20 are longer than thefirst flap17 and extend beyond the first extremity of thesupport11 allows, on one hand, easier manipulation of thebandage10 during its application, and on the other hand, to guarantee, beyond the sterility of the application ofpad13 on the affected area of the epidermis, the sterility of the application of theadhesive side12 of thesupport11 on the patient's skin around the affectedarea22 covered by thesterile pad13. Moreover, thefourth flap20 of the seconddetachable tab15 may have a length greater than that of thesecond flap18 of the firstdetachable tab14 and extend beyond the first extremity of thesupport11 and thesecond flap18.